DEVICE: COBRA (04055207013748)

Device Identifier (DI) Information

COBRA
7326071
In Commercial Distribution
7326071
Richard Wolf GmbH
04055207013748
GS1

1
315304071 *Terms of Use
FIBER-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.3Fr, working channel 1: 3.3Fr, slanted distal tip Ø 6 Fr, TL 1010mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, glass fiber light cable, fiber image carrier, manual focus
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37111 Flexible fibreoptic ureterorenoscope
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, pyelitis, and renal failure. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FAJ Cystoscope and accessories, flexible/rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 3.3 Millimeter
Length: 680 Millimeter
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Device Record Status

c57935cf-19f0-4127-9615-c443f083c520
April 26, 2021
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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